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Immunotherapy for Recurrent High-Grade Glioma in Children and Young Adults

This study is looking at nivolumab, an immunotherapy drug, for children and young adults (ages 6 months to 25 years old) with high-grade glioma (a type of brain tumor) that has returned or is getting worse. You could join if your tumor can be surgically removed. Researchers want to see how nivolumab affects the tumor before and after surgery. They will also track any side effects you might experience for up to two years. The study aims to understand if nivolumab helps the body's immune system fight the cancer. This study is currently recruiting a small group of 9 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 9 participants.
What's involved
You would receive nivolumab before and after surgery. You would also complete quality-of-life assessments and questionnaires, either in person or online.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-related adverse events for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04323046

Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults

Active, Not Recruiting
PHASE1Ages 6–25InterventionalTreatment
Sabine Mueller, MD, PhD
~9 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:NivolumabQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage change in cell cycle-related genetic signature
Measured over From screening to surgery visit (neoadjuvant treatment groups); at time of recurrent high grade glioma (HGG) tissue collection (for archived non-treated samples)
+1 more outcome measured

Conditions

Glioblastoma
Malignant Glioma
Recurrent Glioblastoma
Recurrent Malignant Glioma
Recurrent Grade III Glioma
Grade III Glioma

Explore related trials

GlioblastomaWHO Grade 2 Glioma

Where it's being run

20 sites across 17 states
California3
New South Wales2
Alabama1
District of Columbia1
Florida1
Indiana1
Maryland1
Massachusetts1

Study leadership

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
An interval of at least 12 weeks from the completion of radiation therapy to registration unless there is unequivocal histologic confirmation of tumor progression
Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events (AEs) are known to occur. The duration of this interval must be discussed with the study chair.
Had their last dose of biologic (anti-neoplastic agent) ≥7 days prior to study registration, or beyond the time during which AEs are known to occur.
Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): At least 7 days after the last dose of agent
Interleukins, interferons and cytokines (other than hematopoietic growth factors): \>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
Antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1
An interval of at least 12 weeks from prior exposure to PD-1 or PD-L1 inhibitors.
Stem cell infusion (with or without total-body irradiation (TBI)):
Autologous stem cell infusion including boost infusion: \>= 42 days 11. Participants must be willing to forego cytotoxic anti-tumor therapies except study-defined therapy while being treated on study 12. Organ Function Requirements:
Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
Platelet count \>= 100,000/mm\^3
Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows:
Age: Maximum Serum Creatinine (mg/dL)
6 months to \< 3 years: 0.6 (male and female)
3 to \< 6 years: 0.8 (male and female)
6 to \< 10 years: 1 (male and female)
10 to \< 13 years: 1.2 (male and female)
13 to \< 16 years: 1.5 (male), 1.4 (female)
\>= 16 years: 1.7 (male), 1.4 (female)
Bilirubin (sum of conjugated and unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (except participants with Gilbert syndrome who must have a total bilirubin level of \< 3.0
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN
Serum albumin \>= 2 13. Pregnancy: The effects of nivolumab on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 5 months after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 14. MRI within 28 days prior to registration.

Exclusion

NOTE: Testing for HIV must be performed at sites where mandated locally 15. Any prior positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-ribonucleic acid (RNA) negative). 16. Participants who have had prior allogenic hematopoietic stem cell transplant (HSCT). 17. Any serious or uncontrolled medical disorder that, in the opinion of the investigator may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy or interfere with interpretation of study results.

What this trial measures

  • Percentage change in cell cycle-related genetic signatureFrom screening to surgery visit (neoadjuvant treatment groups); at time of recurrent high grade glioma (HGG) tissue collection (for archived non-treated samples)

    Will assess the percentage change in cell cycle-related genetic signature post administration of neoadjuvant treatments when compared to archived recurrent pediatric HGG group. The number of participants with high cell cycle gene signature (positive median gene set variation analysis (GSVA) score) will be tabulated. Variables involved in the primary analyses will be examined graphically and summarized by descriptive statistics.

  • Proportion of participants with treatment-related adverse eventsUp to 2 years

    Adverse events will be monitored throughout the trial and graded in severity according to the guidelines outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 from initiation of study treatment until 2 years after treatment discontinuation or until study treatment related adverse events resolve or return to baseline, Adverse experiences (specific terms as well as system organ class terms) and predefined limits of change in laboratory, and vital sign parameters that are not pre-specified as events of interest will be summarized with descriptive statistics (counts, percentage, mean, standard deviation, etc.).